Business Model
It seems that most cell therapies target a very specific group of patients that have very few options. We are novel in the fact that our cell therapy is about regenerating a large portion of tissue or even the whole organ. Our main goal is to move research to the product stage, and deliver that product to market. Current Individual stem cell treatments can cost up to $200,000 For project funding apply for grants in the areas that the product applies to until the product can be put to market. For the best profit, sell the finished product not intermediate pieces Business Questions Practicallity and Market *Who would buy it? *Would it be worth it? *Who can it help? *Who could administer or distribute it? *Is it too specific? Cost vs Profit *Is it really worth the investment? *What is the cost of the current comparable treatment? *What is the cost of the equipment needed to produce a finished product? Ingenuity *Is this top of the line? *Is the product something new? *How does this improve on what has already been done? *Does the product offer the kind of top notch quality expected? Complexity *Is the project realistic? *Is the project worth the time and money? *How long will the project take to complete? *What kind of research team and equipment is neccessary? Burns *500,000 treatments per year *4,000 deaths per year *Chronic wounds **5.7 million patients **costs $20 billion anually *Funding to find a cheaper treatment 'The Big Bio-Tech Companies' NeoStem *NeoStem endeavors to be an integrative force in the cell therapy industry by vertically integrating the collection, storage and processing of cell units and he development, manufacturing, distribution, and delivery of cell therapy products *The vatican has contributed $1 million for adult stem cell research, explicitly no ESC research *NeoStem has been awarded a $700,000 contract from the U.S. Army Medical Research and Material Command, Telemedicine and Advanced Technology Research Center (USAMRMC-TATRC). **This contract is for the purpose of evaluating the use of topically applied bone marrow-derived adult mesenchymal stem cells for rapid wound healing. *In September 2009, NeoStem was notified of an award of a Grand Opportunities grant in the amount of $108,746 from the National Institutes of Health, which money will be applied to research in the field of bone defect repair. *In April 2009, NeoStem entered into a License Agreement with Vincent Falanga, M.D., pursuant to which the Company acquired a world-wide, exclusive license to certain innovative stem cell technology and applications for wound healing. **In conjunction with that license the Company entered into a multi-year sponsored research agreement with Roger Williams Medical Center and Dr. Falanga’s laboratory, funded by the Department of Defense, to study the use of VSELs and mesenchymal cells for the treatment of chronic wounds. StemCells *Research, development, and commercialization of stem cell therapeutics and related technologies and tools *Mostly for central nervous system and liver *HuCNS-SC is an allogenic, fetal derived cell product *Myelination disorders like PMD *Totally unment medical need *HuCNS-SCs act to protect photoreceptors and preserve vision in AMD (Age-Related Macular Degeneration) *Has about $27 million in cash Neuralstem *Development and commercialization of treatments for central nervous system disease based on transplanting neural stem cells and the use of small molecule drugs *Generation of physiologically relevant human neurons *One of the only successful clinical trial companies *Intraspinal administration of neural stem cells for ALS treatment *Phase I trials in NYC *Phase II trials in Mexico City, Mexico *Science is interesting but lack of capital and infrastructure is problematic * Doing active trials in Mexico and China and send patients overseas for treatment **Trying to go around the FDA that is slow to give approval *Burning $2.7 out of $10 million they have in 1st quarter of 2012 Pluristem Therapeutics *Research, development, and commercialization and standardized cell therapy products and related technologies for the treatment of life threatening diseases *Products derived from human placenta *Placental adherant stromal cells are grown in the companies proprietary PluriX 3-dimensional process that allows cells to grow in a natural enivronment know as PLX *Have demonstrated that their PLX cells are potent cellsthat appear to be immune priveleged *Has about $65 million in cash Aastrom Biosciences *Has about $24 million in cash *Ixmyelocel-T enables the manufacturing of multicellular therapies expanded from an adult's own bone marrow and be delivered directly to damaged tissues *50 cc take and the 'good' cells are isolated and expanded *Believe they have the right mixture of cells to make cytokines Osiris Therapeutics (smaller) UK Stem Cell Bank *Free ESC lines that are safe to use in medical applications *Two hESC lines are freeas long as it is for research No Results = No Money *Need to produce visible results and progress *Start small scale **Short simple projects Redefining A Cure: What A Stem Cell Therapy For HIV Reminds Us About CLinical Translation Original Article *There are 34 million people living with HIV * Scientists used a bone marrow transplant and kept patients on antiviral drugs **AVRs protect new cells while they kill off infected host cells *Unlikely to be implemented due to costs and risks **Not realistic if not scalable, affordable and accessible *Remember that the point is to make money. We can't help people without it Stem Cell Research Continues To Make Major Breakthroughs Original Article *Stem cell stocks have been gaining popularity among investors in 2012 **New research continues to propel the industry forward *Five Star Equities **Examine the outlook for companies in the Biotechnology Industry and provides equity research on StemCells Inc. and Neuralstem Inc. **Releases merket updates so investors can stay ahead of the curve *Use this to see what the market looks like and to keep up with what the competition is doing and what people are willing to invest in given what the companies tell them. **Ex. (good/bad news or future trials) Deaf Gerbils Are All Ears Thanks To Stem Cells Original Article *Auditory neuropathy affects 300,000 people in the United Kingdom alone *There was an average healing of 46% in mice and gerbils **This is a huge difference for people **From hearing nothing or muffled to being able to carry on conversations, just not wispers *If hair cells can be replaced, we can treat 80-90% of all deaf people Stem Cells Inc. And R-Biomedical Have Partnered *To commercialize a range of cell lines and reagents to facilitate iPSC based research *1st product "ultra-primary" human fibroblast cell line **From this other cell lines can be derived *Super ethical Standing By For Stem Cells Original Article *Thousands of people are affected by cystic fibrosis *Conneticut is amoung a handful of states to reject the White House's position by financing ebryonic stem cell research on their own *10 year program vs California's $3 billion plan *$20 million, but most of it goes to the University of Conneticut and Yale *Doesn't have to be embryonic stem cell research, it can have to do with Biomaterials for expansion *Look into California and possibly Conneticut for research funding *Also, the fact that biomaterials fall under the funding umbrella, opens a lot of doors Complete 2012 Induced Pluripotent Stem Cell Industry Report Original Article *By 2010 Advanced Cell Technology was slowed by the FDA due to premature cell death, cancer risk, and low cell count yeild *iPSCs are now sold by 53,4% of US research product companies and 38.7% of companies world wide **has been growing at a rate of 14.7% per year *To benefit from this lucrative product market you need to anticipate the and serve the needs of your clinets at the same time **Otherwise your competitors will Maxim Group Highlights 3 Stem Cell Stocks To Consider And 1 To Avoid Original Article *The stem cell market is expected to witness a substantial growth in the upcoming years. **To be worth about $64 billion by 2015 **About $21.5 billion in 2010 exhibiting a triple fold growth rate * Aastrom Biosciences **Has about $24 million in cash **Ixmyelocel-T enables the manufacturing of multicellular therapies expanded from an adult's own bone marrow and be delivered directly to damaged tissues **50 cc take and the 'good' cells are isolated and expanded **Believe they have the right mixture of cells to make cytokines * Pluristem Therapeutics **Research, development, and commercialization and standardized cell therapy products and related technologies for the treatment of life threatening diseases **Products derived from human placenta **Placental adherant stromal cells are grown in the companies proprietary PluriX 3-dimensional process that allows cells to grow in a natural enivronment know as PLX **Have demonstrated that their PLX cells are potent cellsthat appear to be immune priveleged **Has about $65 million in cash * StemCells **Research, development, and commercialization of stem cell therapeutics and related technologies and tools **Mostly for central nervous system and liver **HuCNS-SC is an allogenic, fetal derived cell product **Myelination disorders like PMD **Totally unment medical need **HuCNS-SCs act to protect photoreceptors and preserve vision in AMD (Age-Related Macular Degeneration) **Has about $27 million in cash * Nerual Stem **Development and commercialization of treatments for central nervous system disease based on transplanting neural stem cells and the use of small molecule drugs **Generation of physiologically relevant human neurons **Science is interesting but lack of capital and infrastructure is problematic ** Doing active trials in Mexico and China and send patients overseas for treatment ***Trying to go around the FDA that is slow to give approval **Burning $2.7 out of $10 million they have in 1st quarter of 2012 Making Effective Regenerative Medicine Decisions Original Article *The Regenerative Medicine field is rapidly evolving with a variety of adult and non-adult tissue resources **growing involvment of academia, non-profit, for-profit, regulatory, and government organizations *Regenerative Medicine has the capacity to address unmet clinical needs and significantly improve on present therapies *The Regerative Medicine portfolio is growing exponentially, but successful product outcomes are still difficult to predict *TEMPO metrics help decision making for investors **(T) Translational Capabilities **(E) Exclusivity in the Current and Emergent Market Spaces **(M) Manufacturing, Monetary, and Regulatory Hurdles **(P) Proprietary Exclusivity and Challenges **(O) Operational Challenges *Decisions on which factors to concentrate on are critical for the success of the investor Business Plan http://www.score.org/resources/business-plans-financial-statements-template-gallery https://www.enloop.com/ *For investors make a slide deck **10 slides #Have someone who is not involved in your jargon or words to completely understand what results you can achieve for your particular market not intricate details how #Identifying the problem you solved up front #Your solution #Market size, show that you know it more that anyone else, bigger is better, take average transactions size in your market by numbers of people in market #Buisness Model, How do you make money #Your proprietary technology --> what you actually have #Describe your competition, list all #Marketing Plan, describe specifically how you want to get your customers #Your team, show off whos involved, showing credibility, people like geeks, proven enterprenuers, and marketing and sales people #Financial Model, key matrix or model or milestone The more you can do without investors the better your value *Having ID and a good team *If people and market is ready and big *Eliminate doubts about seeing their money again Dont start with name and stuff *Start with what you are going to tell them about or hook *Most prewritten buisness plan are written for banks and are boring *For investors, your buisness plan is your marketing documents, sells you and your buisness *You want an investor to ask more, to engage in conversation 7 Biggest Mistakes #Not writting the plan as a marketing document #Not defining market size --> this to dominate 60% 80% #Undefined financial figures #No focus or customer needs #Trying to solve a problem that doesnt exist #All product and no execution --> you want to be almost no product #Thinking that they have no competition Never say that you have a really good "idea" *A quality buisness *Make them invest in a no brainer Eight Reasons Startup Incubators Are Better Than Buisness School *Customsers dont give a damn about your degrees *Applying to a startup incubator may be better than buisness school *Incubators have been around, usually attached to universities *A new breed of incubators has popped up, catering to technology **Offer mentorship, office space, legal counsel, and even spend money for equity You Cant Teach Entrepeneurship *You will never be fully prepared to create a buisness *You can learn more by actually running a company and by talking to others who are running companies *Doesnt come with an MBA's pricetag or boring classes Eating Ramen Earns Respect *Bootstrapping sucks *Incubators love the suffer-for-your-startup story Spending $100,000 Isnt Cool (You Know What Is Cool? Getting $100,000) *The idea that you can start a company with a fancy degree and $100,000 in loans is a joke *Even without debt, seed money is tough to find **Incubators make it a whole lot easier *Give you money for 6-8% equity Investors Like Incubators *Most incubators culminate in one demo day *Entrepreneurs pitch their companies to investors who matter **Investors trust these programs to do a lot of the diligence for them and carry a brand name with Your Business Is the Best Case Study *Most incubators assign a squad of startup veterans to your venture *Its like the whole faculty is your team **Mentorship at the program is completely customozed for each buisness Time Is Money *You spend more that $100,000 to go to buisness school *Tuition plus no work for 2 years can approach $300,000 **Incubators eat just 3 months The Networking Is Better *Buisness school connections are valuable, but incubators are a better bet *A tight, committed netowrk of advisors is perhaps the most important assets incubators have to offer *The biggest thing you walk away with is five to ten outside people who are deeply engaged in the company Incubators Are Fun *They joy of joining an incubator is intimately connection to the task at hand *Building and selling a real product that come out of your head **Its fun to read your first press converage and clost that first big deal and snare that first big customer Incubators and Accelerators Look into TechColumbus as a top contender if not just for consulting Rankings https://angel.co/incubators http://www.hersheyresearch.com/biotech-incubator.html http://www.sidmartinbio.org/ http://www.momentum-biosciences.com/ http://www.upstate.edu/biocenter/apply.php http://www.sanfordburnham.org/technology/otmc/Pages/Biotechnology%20Accelerator.aspx http://marylandbiocenter.org/resources/pages/Incubators.aspx http://www.limrdevelopment.com/BiotechIncubator.html http://research.downstate.edu/biotech/abi.htm http://www.techmanage.net/resources/?category=14 http://www.slcec.com/helix-center.html http://www.techcolumbus.org/bioscience http://www.ohio.edu/research/innovation/ http://www.utoledo.edu/research/ Crowd Funding/Investing Invested In Bank To The Future Angel List Biotech Supplies *Lifetechnologies *Bio-Rad *Stem Cell Technologies *Applied Stem Cell **ESC's and SC generation and differentiation and staining and staining *Arkonebio **Stem Cell Media *AuxoCell **Cord blood cells